{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,22]],"date-time":"2026-02-22T04:35:38Z","timestamp":1771734938399,"version":"3.50.1"},"reference-count":17,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2018,6,1]]},"abstract":"\n Background:<\/jats:title>\n The integrase inhibitor regimen [elvitegravir\/cobicistat\/emtricitabine\/tenofovir disoproxil fumarate (TDF)] demonstrated superior efficacy when compared with a protease inhibitor regimen [ritonavir-boosted atazanavir (ATV + RTV) and FTC\/TDF] in 575 treatment-naive women at week 48. We investigated the efficacy, safety, and tolerability of switching to a TAF-based, single-tablet regimen containing elvitegravir, cobicistat, FTC, and tenofovir alafenamide (E\/C\/F\/TAF) versus remaining on ATV + RTV plus FTC\/TDF.<\/jats:p>\n <\/jats:sec>\n \n Methods:<\/jats:title>\n After completing the initial randomized, blinded phase, virologically suppressed (HIV-1 RNA <50 copies\/mL) women on ATV + RTV plus FTC\/TDF were rerandomized (3:1) to receive open-label E\/C\/F\/TAF versus remaining on their current regimen. The primary end point was proportion of participants with plasma HIV-1 RNA <50 copies per milliliter at week 48 (U.S. FDA snapshot algorithm), with a prespecified noninferiority margin of 12%. Safety [adverse events (AEs)] and tolerability were also assessed.<\/jats:p>\n <\/jats:sec>\n \n Results:<\/jats:title>\n Of 575 women originally randomized and treated in the blinded phase, 159 were rerandomized to switch to E\/C\/F\/TAF and 53 to remain on ATV + RTV plus FTC\/TDF. At week 48, virologic suppression was maintained in 150 (94%) of women on E\/C\/F\/TAF and 46 (87%) on ATV + RTV plus FTC\/TDF [difference 7.5% (95% confidence interval \u22121.2% to 19.4%)], demonstrating noninferiority of E\/C\/F\/TAF to ATV + RTV and FTC\/TDF. Incidence of AEs was similar between groups; study drug\u2013related AEs were more common with E\/C\/F\/TAF (11% versus 4%).<\/jats:p>\n <\/jats:sec>\n \n Conclusions:<\/jats:title>\n Switching to E\/C\/F\/TAF was noninferior to continuing ATV + RTV plus FTC\/TDF in maintaining virologic suppression and was well tolerated at 48 weeks.<\/jats:p>\n <\/jats:sec>","DOI":"10.1097\/qai.0000000000001663","type":"journal-article","created":{"date-parts":[[2018,2,23]],"date-time":"2018-02-23T20:00:00Z","timestamp":1519416000000},"page":"209-213","source":"Crossref","is-referenced-by-count":16,"title":["Brief Report: Efficacy and Safety of Switching to Coformulated Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide (E\/C\/F\/TAF) in Virologically Suppressed Women"],"prefix":"10.1097","volume":"78","author":[{"given":"Sally","family":"Hodder","sequence":"first","affiliation":[{"name":"West Virginia University Health Sciences Center, Morgantown, WV;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kathleen","family":"Squires","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Thomas Jefferson University, Philadelphia, PA;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cissy","family":"Kityo","sequence":"additional","affiliation":[{"name":"Joint Clinical Research Centre, Kampala, Uganda;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Debbie","family":"Hagins","sequence":"additional","affiliation":[{"name":"Georgia Department of Public Health, Coastal Health District, Chatham Care Center, Savannah, GA;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anchalee","family":"Avihingsanon","sequence":"additional","affiliation":[{"name":"HIV Netherlands Australia Thailand Research Collaboration, The Thai Red Cross AIDS Research Centre;"},{"name":"Faculty Of Medicine, Chulalongkorn University, Bangkok, Thailand; and"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anna","family":"Kido","sequence":"additional","affiliation":[{"name":"Departments of Clinical Research, Biometrics, and Virology, Gilead Sciences, Inc., Foster City, CA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shuping","family":"Jiang","sequence":"additional","affiliation":[{"name":"Departments of Clinical Research, Biometrics, and Virology, Gilead Sciences, Inc., Foster City, CA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rima","family":"Kulkarni","sequence":"additional","affiliation":[{"name":"Departments of Clinical Research, Biometrics, and Virology, Gilead Sciences, Inc., Foster City, CA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Cheng","sequence":"additional","affiliation":[{"name":"Departments of Clinical Research, Biometrics, and Virology, Gilead Sciences, Inc., Foster City, CA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Huyen","family":"Cao","sequence":"additional","affiliation":[{"name":"Departments of Clinical Research, Biometrics, and Virology, Gilead Sciences, Inc., Foster City, CA."}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"276","reference":[{"key":"R2-20230926","doi-asserted-by":"crossref","first-page":"191","DOI":"10.1001\/jama.2016.8900","article-title":"Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2016 recommendations of the International Antiviral Society\u2013USA panel","volume":"316","author":"G\u00fcnthard","year":"2016","journal-title":"JAMA"},{"key":"R4-20230926","doi-asserted-by":"crossref","first-page":"449","DOI":"10.1097\/QAI.0b013e3182965d45","article-title":"Antiviral activity, safety, and pharmacokinetics\/pharmacodynamics of tenofovir alafenamide as 10-day monotherapy in HIV-1-positive adults","volume":"63","author":"Ruane","year":"2013","journal-title":"J 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